ACICLOVIR KERN PHARMA 200 mg DISPERSIBLE TABLETS

Introduction

Patient Information Leaflet

Aciclovir Kern Pharma 200 mg dispersible tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Aciclovir Kern Pharma and what is it used for
2. What you need to know before you take Aciclovir Kern Pharma
3. How to take Aciclovir Kern Pharma
4. Possible side effects
5. Storing Aciclovir Kern Pharma
6. Contents of the pack and further information

1. What is Aciclovir Kern Pharma and what is it used for

Aciclovir is an antiviral medicine used to treat infections caused by viruses.

This medicine is indicated for the treatment of: skin and mucous membrane infections caused by the herpes simplex virus in immunocompromised patients (weakened immune system) and its prevention, genital herpes (being effective in the first episode of genital herpes), herpes zoster in immunocompetent patients (with normal immune system function) and chickenpox.

It is also indicated in patients at risk (diabetics, malnourished, etc.) and/or with severe herpes zoster, with the benefit being lower in the rest of the patients.

2. What you need to know before taking Aciclovir Kern Pharma

Do not takeAciclovir Kern Pharma

If you are allergic (hypersensitive) to aciclovir or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

• If you have kidney disease or are elderly, your doctor may use a lower dose. Also, you should drink enough fluid during treatment to maintain adequate hydration.
• In elderly patients, adequate fluid intake is recommended while taking high doses of aciclovir orally.
• Caution should be taken to avoid potential transmission of the virus, especially when active lesions are present. To avoid transmission of the infection to your partner, patients with genital herpes with visible lesions should avoid sexual intercourse.

Children and adolescents

This medicine is recommended for the treatment and prevention of infections caused by the herpes simplex virus in immunodeficient children. See section 3. How to take Aciclovir Kern Pharma.

There is no established dosage for the treatment of recurrent herpes simplex virus infections in immunocompromised children.

For the treatment of chickenpox in children under 2 years of age, see section 3. How to take Aciclovir Kern Pharma.

For the treatment of chickenpox in children over 6 years of age, other presentations are more suitable.

Taking Aciclovir Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including those obtained without a prescription.

Concomitant administration with probenecid (a medicine used to treat gout), cimetidine (a medicine for the treatment of stomach acid), or mycophenolate (to prevent organ transplant rejection) increases the half-life of aciclovir and the area under the curve of its plasma concentrations, which should be taken into account by your doctor, although no dose adjustment is necessary.

No other drug interactions have been described, although medications that alter renal physiology could influence the pharmacokinetics of aciclovir.

Taking Aciclovir Kern Pharma with food and drinks

Aciclovir tablets can be dispersed in a minimum of 50 ml of water or swallowed whole with a little water.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

Human experience is limited, so aciclovir will only be used in cases where the benefit-risk assessment of its application advises its use.

Breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Studies in humans show that after administration of this medicine, aciclovir may appear in breast milk, so breastfeeding should be replaced.

Driving and using machines

Due to the characteristics of this medicine, it is unlikely. However, it has been observed that in some cases, signs of fatigue, headache, and mild neurological reactions occur. These reactions should be taken into account when driving and operating machinery.

3. How to take Aciclovir Kern Pharma

The first dose should be administered as soon as possible after the infection has developed.

In the case of recurrent infections, it will be convenient to start treatment at the first symptom or sign, or when lesions appear.

Follow these instructions unless your doctor has given you different instructions. Remember to take your medicine.

Aciclovir tablets can be dispersed in a minimum of 50 ml of water or swallowed whole with a little water. The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Your doctor will indicate the duration of your treatment with this medicine. Do not stop treatment before.

Adults:

Patients with normal renal function:

• For the treatment of infections caused by the herpes simplex virus: 1 tablet 5 times a day at intervals of approximately 4 hours, omitting the night dose, for 5 days.

In patients who are severely immunocompromised and those with difficulties in intestinal absorption, the dose may be doubled to 400 mg (2 tablets) 5 times a day.

• For the suppression of recurrences caused by the herpes simplex virus in immunocompetent patients (with normal immune system function): 1 tablet 4 times a day at intervals of approximately 6 hours or 2 tablets 2 times a day, every 12 hours. Treatment will be interrupted periodically at intervals of 6 to 12 months to observe possible changes in the disease process.
• For the prevention of infections caused by the herpes simplex virus in immunocompromised patients: 1 tablet 4 times a day at intervals of 6 hours. In patients who are severely immunocompromised and those with difficulties in intestinal absorption, the dose may be doubled to 400 mg (2 tablets) 4 times a day.
• For the treatment of herpes zoster infections: 4 tablets of 200 mg 5 times a day at intervals of 4 hours, omitting the night dose, for 7 days.

Patients with altered renal function:

• In the treatment of infections caused by the herpes simplex virus, in patients with a creatinine clearance equal to or less than 10 ml/minute, 1 tablet every 12 hours.
• In the treatment of herpes zoster infections, 4 tablets of 200 mg 2 times a day are recommended for patients with a creatinine clearance less than 10 ml/minute and 4 tablets of 200 mg 3 or 4 times a day at intervals of 6-8 hours for patients with a creatinine clearance of 10-25 ml/minute.

Elderly patients

• In elderly patients, adequate fluid intake is recommended while taking high doses of aciclovir orally.
• In elderly patients with altered renal function, a reduced dose will be administered.

Pediatric population

• For the treatment of infections caused by the herpes simplex virus and prevention in immunocompromised children:

• Children over 2 years of age: will be treated with adult doses.
• Children under 2 years of age: will be treated with half the adult dose.

• For the treatment of chickenpox:

• Children between 2 and 6 years of age: 2 tablets of 200 mg 4 times a day for 5 days.
• Children under 2 years of age: 1 tablet of 200 mg 4 times a day for 5 days.

The dosage can be calculated more accurately as 20 mg per kg of body weight (not exceeding 800 mg 4 times a day).

If you take moreAciclovir Kern Pharma than you should

Since aciclovir is only partially absorbed by the digestive tract, it is unlikely that serious toxic effects will occur after ingestion of 5 g of aciclovir in a single dose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

Information for healthcare professionals in case of overdose

Aciclovir is dialyzable. Hemodialysis significantly increases the elimination of aciclovir from the blood and may, therefore, be considered a treatment option in case of symptomatic overdose.

If you forget to take Aciclovir Kern Pharma

Do not take a double dose to make up for forgotten doses, simply continue with your usual treatment as soon as possible.

If you stop taking Aciclovir Kern Pharma

Do not stop treatment before your doctor advises, as your cure may not be complete and your illness may recur.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people): headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, itching, skin rashes (including photosensitivity), fatigue, fever.

Uncommon (may affect up to 1 in 100 people): hives, accelerated and diffuse hair loss.

Rare (may affect up to 1 in 1,000 people): difficulty breathing, reversible increase in bilirubin and related liver enzymes, skin inflammation, increased urea and creatinine in blood, severe allergic reaction throughout the body.

Very rare (may affect up to 1 in 10,000 people): decrease in blood cell counts, hepatitis, jaundice (yellowing of the skin), acute kidney failure, kidney pain.

This medicine may cause other very rare side effects such as agitation, confusion, tremors, difficulty moving, difficulty speaking, confusion or imagining things (hallucinations), seizures, drowsiness, encephalopathy (brain disorder), coma. These effects are generally reversible and usually affect patients with renal impairment or other predisposing factors (see section Warnings and precautions).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Aciclovir Kern Pharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Aciclovir Kern Pharma

• The active substance is aciclovir. Each tablet contains 200 mg of aciclovir.

• The other ingredients are: microcrystalline cellulose, povidone K-30, aluminum and magnesium silicate, magnesium stearate, sodium carboxymethylcellulose (type A) (derived from potato starch), indigo carmine (E-132), polyethylene glycol 400 and 8000, hydroxypropylmethylcellulose.

Appearanceof the product and pack contents

Dispersible tablets, round, coated, blue, scored on both sides. The score line is for breaking and facilitating swallowing but not for dividing into equal doses.

Each pack contains 25 or 100 tablets, packaged in PVC/PVDC/Al blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this leaflet:April 2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.